Task I: Single-dose Pharmacokinetic Study The Contractor shall develop a single-dose phase 1 clinical protocol for a variety of agents to evaluate the parameters of drug absorption, plasma concentration-time profiles, distribution (in relevant tissues, where feasible), excretion and toxicity. Task II: Multiple-dose Safety and Pharmacokinetic Study The Contractor shall develop a multiple-dose safety and pharmacokinetic phase 1 clinical protocol for the chemopreventive agents to evaluate the parameters of safety and toxicity and of steady state pharmacokinetics. In addition, investigations of pharmacological and/or cancer surrogate endpoint biomarker modulation may be undertaken. Protocol activation for Task I and Task II will occur following IRB and FDA approval and the receipt of all chemopreventive drugs from the NCI review, and subunit a finalized protocol for IRB approval. The Contractor shall prepare all materials necessary for FDA approval. The NCI will submit the protocol to the FDA and will hod the IND.